Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]Flutemetamol Positron Emission Tomography (PET) Images

GE Healthcare276 enrolled

Overview

To Evaluate the Effectiveness of an Electronic Training Program for Orienting and Interpreting \[18F\]flutemetamol Positron Emission Tomography (PET) Images.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

276

Conditions

Alzheimer's Disease Mild Cognitive Impairment

Interventions

[18F]FlutemetamolDRUG

No drug is administered in this intervention. These are scanned images being reviewed, previously acquired in various GE-067 studies.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subject received a dose of Flutemetamol F 18 Injection ranging from approximately 185 MBq to approximately 370 MBq. * The subject was classified as one of the following: 1. End-of-life subject who expired and underwent brain autopsy, with histochemical (HC) confirmation of brain amyloid status. 2. Subject with known/suspected normal pressure hydrocephalus (NPH) who underwent brain biopsy, with HC confirmation of brain amyloid status. 3. Elderly healthy volunteer (age ≥55). 4. Young healthy volunteer (age ≤40). 5. Subject with probable Alzheimer Disease (pAD). 6. Subject with amnestic Mild Cognitive Impairment (aMCI). Exclusion Criteria: * Not Applicable

Outcomes

Primary Outcomes

Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images.

Statistical analysis of summary of the blinded visual PET Image Interpretations without Anatomic Images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study. These Readers examined the PET images for evidence of amyloid plaque.

Time frame: Post flutemetamol administration

Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images.

Statistical analysis of summary of sensitivity of blinded visual PET image interpretations without anatomic images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study.These Readers examined the PET images for evidence of amyloid plaque.

Time frame: Post flutemetamol administration

Secondary Outcomes

Inter-Reader Agreement of PET Images Without Anatomic Images

Statistical analysis of Inter-Reader Agreement of PET Images without anatomic Images. This data consists of image interpretations by investigators and No subjects were dosed in this study.

Time frame: Post Flutemetamol Injection

Data from ClinicalTrials.gov

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